Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)

University of Pittsburgh

Status and phase: Terminated; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: start cozaar; Other: no drug; Drug: continue cozaar

Study type: Interventional

Funder types: Other

Identifiers

NCT01233635

0507061

Details and patient eligibility

About

In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims:

1. To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
2. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele.
3. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must be in atrial fibrillation confirmed by 12 lead EKG.
• blood pressure > 90 mmHg
• Patient without cardiopulmonary symptoms
• 18+ years of age

Exclusion criteria

• Contraindiction to warfarin
• Recent (within 6 months) MI or cardiac revascularization
• Recent (within 6 months) CVA or TIA
• NYHA Class IV CHF
• Active thyroid disease
• Major hepatic dysfunction
• Renal dysfunction (>2 mg/dL)
• Hyperkalemia (>4.6 mEq/L)
• Hyponatremia (<130 mEq/L)
• Currently taking a Vaughn-Williams Type I or III antiarrhythmic drug
• History of ARB intolerance
• Contraindication to ARB therapy
• Pregnancy
• Female of childbearing age
• Age < 18 years of age
• Inability to give informed consent
• Other medical conditions calling 1 year survival into question

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 3 patient groups

A Group 1 no drug

Experimental group

Description:

Patients who have not taken ACE/ARB, randomized to no drug.

Treatment:

Other: no drug

A Group 2

Experimental group

Description:

Patients who have not taken ACE/ARB, randomized to take cozaar.

Treatment:

Drug: start cozaar

B

Experimental group

Description:

Patients currently taking ACE/ARB will have their prescription changed to cozaar.

Treatment:

Drug: continue cozaar